Neoadjuvant Combination Therapy of Lenvima® plus Transcatheter Arterial Chemoembolization (TACE) for Transplant-Eligible Patients with Large Hepatocellular Carcinoma

Investigator: Maen Abdelrahim, MD

Study Coordinator:

Status: Open Not Enrolling

ClinicalTrials.gov Number: N/A

Phone:

Protocol Number: PRO00028690

Description

We propose a regimen of six months neoadjuvant lenvatinib in combination with transcatheter arterial chemoembolization (TACE) prior to liver transplantation in patients with hepatocellular carcinoma (HCC) beyond Milan Criteria. Clinical, outcomes, and exploratory data will be compared to a matched, retrospective cohort. HCC is the third leading cause of cancer death worldwide with more than 230,000 cases of HCC since 2000 and an estimated 42,000 new cases next year. The purpose of this trial is to examine if combination therapy of lenvatinib (LENVIMA®, Eisai Inc., Woodcliff Lake, NJ) plus transcatheter arterial chemoembolization (TACE) will promote tumor necrosis evidenced by explant pathology in patients with large HCC (>5 cm). TACE blocks blood supply to the tumor and induces tumor necrosis, but this causes hypoxia and subsequent angiogenesis.
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